Paracetamol Tablets Bp 500mg
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Paracetamol Tablets BP 500mg
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 500mg Paracetamol BP.
For a full list of excipients, see Section 6.1.
3 PHARMACEUTICAL FORM
Uncoated Tablet.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Paracetamol is a mild analgesic and antipyretic. The tablets are recommended for the treatment of most painful and febrile conditions, for example, headache including migraine and tension headaches, toothache, neuralgia, backache, sore throat, for relieving the fever, aches and pains of colds, influenza, rheumatic pain, muscle pains and dysmenorrhea. Also recommended for the symptomatic relief of pain due to nonserious arthritis.
4.2 Posology and method of administration
Posology
Dose (unless otherwise directed by a doctor):
Adults, including the elderly, and children over 12 years:
One to two tablets every 4-6 hours as required, to a maximum of 8 tablets daily in divided doses.
Children aged 6 to 12 years:
Half to one tablet every 4-6 hours as necessary, to a maximum of 4 tablets daily in divided doses. Children should not be given Paracetamol 500mg Tablets for more than 3 days without consulting a doctor.
Children under 6 years:
Not suitable for children under 6 years.
These dosages should not be given more frequently than every 4 hours. Not more than 4 doses should be taken in any 24 hours.
Method of administration
For oral administration
4.3 Contraindications
Hypersensitivity to Paracetamol and/or any of the other constituents in the tablets.
4.4 Special warnings and precautions for use
Care is advised in the administration of paracetamol to patients with alcohol dependency (see Section 4.9), severe renal or severe hepatic impairment. The hazards of overdose are greater in those with non-cirrhotic alcoholic liver disease.
Patients should be advised to consult their doctor if their headaches become persistent.
Patients should be advised not to take other paracetamol-containing products concurrently.
Patients should be advised to consult a doctor if they suffer from non-serious arthritis and need to take painkillers every day.
Paracetamol Tablets BP 500mg contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Leaflet and Label warnings:
Do not take more medicine than the label tells you to.
If symptoms persist consult your doctor.
KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
Immediate medical advice should be sought in the event of an overdose, even if you feel well, because of the risk of delayed, serious liver damage.
Do not take with any other paracetamol-containing products.
If symptoms persist for more than 3 days or get worse consult your doctor.
4.5. Interaction with other medicinal products and other forms of interaction
Anti-coagulants: The anticoagulant effect of warfarin and other coumarins may be enhanced by prolonged regular daily use of paracetamol with increased risk of bleeding; occasional doses have no significant effect.
Anti-epileptics: metabolism of paracetamol possibly accelerated by carbamazepine.
Cyto-toxics: paracetamol possibly inhibits metabolism of intravenous busulfan (manufacturer of intravenous busulfan advises caution within 72 hours of paracetamol).
Cholestyramine: The speed of absorption of paracetamol is reduced by cholestyramine. Therefore, cholestyramine should not be taken within one hour if maximal analgesia is required.
Metoclopramide and Domperidone: The absorption of paracetamol is increased by metoclopramide and domperidone. However, concurrent use need not be avoided.
Chloramphenicol: Increased plasma concentration of chloramphenicol.
Imatinib: Restriction or avoidance of concomitant regular paracetamol use should be taken with imatinib.
4.6 Fertility, pregnancy and lactation
Pregnancy
Epidemiological studies in human pregnancy have shown no ill effects due to Paracetamol used in the recommended dosage, but patients should follow the advice of their doctor regarding its use.
Breast-feeding
Paracetamol is excreted in breast milk but not in a clinically significant amount. Available published data do not contraindicate breast-feeding.
4.7 Effects on ability to drive and use machines
None known
4.8 Undesirable effects
Adverse effects of Paracetamol from historical clinical trial data are both infrequent and from small patient exposure. Accordingly, events reported from extensive postmarketing experience at therapeutic/labelled dose and considered attributable are tabulated below by system class. Due to limited clinical trial data, the frequency of these adverse events is not known (cannot be estimated from available data), but postmarketing experience indicates that adverse reactions to paracetamol are rare and serious reactions are very rare.
Very rare cases of serious skin reactions have been reported.
Post marketing data:
Blood and lymphatic system disorders
Blood dyscrasias including: Thrombocytopenia, agranulocytosis, neutropenia, pancytopenia and leukopenia
Immune system disorders
Anaphylaxis
Cutaneous hypersensitivity reactions including skin rashes, angioedema and Stevens Johnson syndrome/toxic epidermal necrolysis
Respiratory, thoracic and mediastinal disorders
Bronchospasm*
Hepatobiliary disorders Hepatic dysfunction
* There have been cases of bronchospasm with paracetamol, but these are more likely in asthmatics sensitive to aspirin or other NSAIDs.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at:www.mhra. gov.uk/yellowcard.
4.9 Overdose
Paracetamol
Liver damage is possible in adults who have taken 10g or more of paracetamol. Ingestion of 5g or more of paracetamol may lead to liver damage if the patient has risk factors (see below).
Risk Factors
If the patient
(a) Is on long term treatment with carbamazepine, phenobarbitone, phenytoin, primidone, rifampicin, St. John’s Wort or other drugs that induce liver enzymes.
Or
(b) Regularly consumes ethanol in excess of recommended amounts.
Or
(c) Is likely to be glutathione deplete e.g. eating disorders, cystic fibrosis, HIV infection, starvation, cachexia.
Symptoms
Symptoms of Paracetamol overdosage in the first 24 hours are pallor, nausea, vomiting, anorexia and abdominal pain. Liver damage may become apparent 12 to 48 hours after ingestion. Abnormalities of glucose metabolism and metabolic acidosis may occur. In severe poisoning, hepatic failure may progress to encephalopathy, haemorrhage, hypoglycaemia, cerebral oedema and death. Acute renal failure with acute tubular necrosis, strongly suggested by loin pain, haematuria and proteinuria, may develop even in the absence of severe liver damage. Cardiac arrhythmias and pancreatitis have been reported.
Management
Immediate treatment is essential in the management of paracetamol overdose. Despite a lack of significant early symptoms, patients should be referred to hospital urgently for immediate medical attention. Symptoms may be limited to nausea or vomiting and may not reflect the severity of overdose or the risk of organ damage. Management should be in accordance with established treatment guidelines, see BNF overdose section.
Treatment with activated charcoal should be considered if the overdose has been taken within 1 hour. Plasma paracetamol concentration should be measured at 4 hours or later after ingestion (earlier concentrations are unreliable). Treatment with N-acetylcysteine may be used up to 24 hours after ingestion of paracetamol, however, the maximum protective effect is obtained up to 8 hours post-ingestion. The effectiveness of the antidote declines sharply after this time. If required the patient should be given intravenous N-acetylcysteine, in line with the established dosage schedule.
If vomiting is not a problem, oral methionine may be a suitable alternative for remote areas, outside hospital. Management of patients who present with serious hepatic dysfunction beyond 24 hours from ingestion should be discussed with the NPIS or a liver unit.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: anilides ATC code: N02B E01
Paracetamol has analgesic and antipyretic effects but has only weak antiinflammatory effects. These actions are considered to be due to inhibition of biosynthesis of prostaglandins.
5.2 Pharmacokinetic properties
Paracetamol is readily absorbed from the gastro-intestinal tract with peak plasma concentrations occurring about 30 minutes to 2 hours after ingestion. It is metabolised in the liver and excreted in the urine mainly as the glucuronide and sulphate conjugates. Less than 5% is excreted as unchanged Paracetamol The elimination half-life varies from 1-4 hours.
Plasma protein binding is negligible at usual therapeutic concentrations but increases with increasing concentrations. A minor hydroxylated metabolite which is usually produced in very small amounts by mixed function oxidizes in the liver and which is usually detoxified by conjugation with liver glutathione may accumulate following Paracetamol overdosage and cause liver damage.
Practically no Paracetamol is excreted unchanged, and the bulk is excreted after hepatic conjugation with glycuronic acid (about 60%) sulphuric acid (about 35% or cysteine (about 3%).
Children have less capacity for glucuronidation of the drugs than do adults. When high doses are ingested Paracetamol undergoes N-hydroxylation to form N-Acetyl-Benzo Quinoneimine, a highly reactive intermediate. This metabolites reactions with sulfhydryl groups in proteins and gluthatione. When hepatic glutathione is depleted reaction with hepatic proteins is increased and hepatic necrosis is the result. A review of the absorption and fate and bioavailability of Paracetamol was carried by Hunt et Al.
5.3 Preclinical safety data
There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Maize starch Lactose
Povidone
Magnesium Stearate Sodium Starch Glycollate Colloidal Silicon Dioxide Purified Water 6.2 Incompatibilities
Nothing stated
6.3 Shelf life
5 years (blisters and containers).
6.4 Special precautions for storage
Store below 25oC in a dry place. Store in the original package.
KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
6.5 Nature and contents of container
Blister strips (composed of PVC film and aluminium foil):
10,12, 16, 20, 24, 30, 32, 40, 48, 50, 60, 70, 80, 90, 96, 100
Polypropylene/polyethylene packs:
5000, 1000, 500, 100, 90, 80, 70, 60, 50, 40, 32, 30, 25, 20, 16, 10
Not all pack sizes may be marketed.
6.6 Special precautions for disposal
None.
7 MARKETING AUTHORISATION HOLDER
Athlone Pharmaceuticals Limited Ballymurray
Co.Roscommon
Ireland
8 MARKETING AUTHORISATION NUMBER(S)
PL 30464/0062
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
28th May 1981
10 DATE OF REVISION OF THE TEXT
08/07/2016
11 DOSIMETRY (IF APPLICABLE)
INSTRUCTIONS FOR PREPARATION OF RADIOPHARMACEUTICALS (IF APPLICABLE)
12